BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDE RAAA ENDOPROSTHESIS

    MDR report key: 3143085 · Received May 28, 2013

    Report

    Report Number
    2017233-2013-00342
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. WHEN THE PHYSICIAN IMPLANTED A CONTRALATERAL LEG COMPONENT ON THE LEFT SIDE, THE DEVICE PARTIALLY DEPLOYED IN THE EXTERNAL ILIAC ARTERY, COVERING THE HYPOGASTRIC ARTERY. FINAL ANGIOGRAPHY SHOWED NO OTHER PROBLEMS. THE PATIENT TOLERATED THE PROCEDURE. THE DEVICE WAS LEFT COVERING THE HYPOGASTRIC ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233519 GORE EXCLUDE RAAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 11121286

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other